MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK; GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S3

Model Number	02.12.E003RP
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a knee infection and the pathogen is unknown.At about 3 months from primary the surgeon performed a washout and revised the patella and femoral component to a same size patella and femoral component.The surgeon revised the 10mm insert and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch reviews performed on 09 april 2026: gmk-spherika 02.12.E003rp gmk-sphere resurfacing patella e-cross - s3 (k202022) lot 2513565: (b)(4) items manufactured and released on 16-sep-2025.Expiration date: 2030-jun-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Gmk-spherika 02.12.E0210fr gmk-sphere tibial insert e-cross - flex 2r - 10mm (k202022) lot 2518416: (b)(4) items manufactured and released on 17-sep-2025.Expiration date: 2030-set-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Gmk-spherika 02.12.Ka03r gmk spherika femoral component s3r cemented (k211004) lot 2520845: (b)(4) items manufactured and released on 12-nov-2025.Expiration date: 2030-oct-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause:infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: GMK
• Common Device Name: GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S3
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25039770
• Report Number: 3005180920-2026-00358
• Device Sequence Number: 18744631
• Product Code: JWH
• UDI-Device Identifier: 07630971260993
• UDI-Public: 07630971260993
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.12.E003RP
• Device Lot Number: 2513565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female